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Sublingual Misoprostol for the Treatment of Incomplete Abortion: Operations Research

Sponsor
Gynuity Health Projects (Other)
Overall Status
Completed
CT.gov ID
NCT02707653
Collaborator
Department of Medical Research, Lower Myanmar (Other)
75
Enrollment
2
Locations
1
Arm
8
Actual Duration (Months)
37.5
Patients Per Site
4.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will investigate the use of misoprostol for first-line treatment of incomplete abortion at tertiary hospitals in Myanmar.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

This open-label feasibility study seeks to examine the potential of 400μg sublingual misoprostol for the treatment of incomplete abortion provided at tertiary hospitals.

Study Design

Study Type:
Interventional
Actual Enrollment :
75 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Sublingual Misoprostol for the Treatment of Incomplete Abortion: Operations Research
Actual Study Start Date :
Mar 1, 2016
Actual Primary Completion Date :
Nov 1, 2016
Actual Study Completion Date :
Nov 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Other: Miso

Misoprostol 400 s/l

Drug: Misoprostol
400 mcg sublingual misoprostol
Other Names:
  • cytotec

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of women with complete uterine evacuation with study medication alone. [14 days]

    Secondary Outcome Measures

    1. Percentage of women experiencing side effects [7-14 days]

      occurrence of side effects, if any, including fever, chills, nausea, vomiting, headache, diarrhea, and pain.

    2. Level of self-reported acceptability of treatment [7-14 days]

      Woman's satisfaction with the treatment, woman's likelihood to use the treatment in the future, woman's likelihood of recommending the treatment to a friend, providers' satisfaction with the treatment, likelihood provider would recommend the treatment in a similar situation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 55 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Confirmed incomplete abortion

    2. No known contraindications to the study drug

    3. Uterine size no larger than 12 weeks at time of presentation for care

    4. No signs of severe infection, defined as at least two of the following:

    • foul smelling discharge,

    • fever > 38 degrees C, 100 degrees Fahrenheit

    • uterine tenderness.

    1. No hemodynamic disturbances (pulse >110/min and systolic bp <100)

    2. General good health

    3. Agree to comply with study procedures including return for follow up visit

    4. Live or work within one hour from a study site

    5. Willing and able to sign consent forms

    Exclusion Criteria:
    1. Inability to provide informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Central Woman's Hospital Yangon Myanmar
    2 Thingyan Sanpya Hospital Yangon Myanmar

    Sponsors and Collaborators

    • Gynuity Health Projects
    • Department of Medical Research, Lower Myanmar

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gynuity Health Projects
    ClinicalTrials.gov Identifier:
    NCT02707653
    Other Study ID Numbers:
    • 2001
    First Posted:
    Mar 14, 2016
    Last Update Posted:
    Jun 12, 2018
    Last Verified:
    Jun 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Abortion, Incomplete
    Misoprostol

    Study Results

    No Results Posted as of Jun 12, 2018